Quality Engineer: Design, PDP & Continuous Improvement

Markent Personnel; Bay Shore (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

Markent Personnel is seeking a Quality Engineer to ensure quality standards across the product development lifecycle, from design through post-market support. You'll participate in QD&D during design, support PDP activities, and ensure regulatory compliance.

You will lead root-cause analysis, drive CAPA, collaborate with engineering, manufacturing, and supply chain, and promote continuous improvement with data-driven metrics.

Qualifications

• Bachelor’s degree in engineering or quality management required.
• Experience as a Quality Engineer in manufacturing or product development.
• Strong knowledge of QA methodologies, development processes, and regulatory requirements.
• Proficient in risk management, RCA, and CAPA processes.
• Excellent communication and problem-solving skills.
• Certification in quality management systems (e.g., Six Sigma, ASQ CQE) is a plus.

Responsibilities

• Quality Design & Development: support QD&D activities during PDP and ensure requirements are defined and followed.
• Participate in PDP planning, execution, and monitoring of QA measures including risk assessments and design validation.
• Provide ongoing quality support to sustaining manufacturing teams and lead root cause analysis.
• Ensure quality during product distribution and support post-market surveillance activities.
• Maintain regulatory compliance (ISO, FDA) and support audits and documentation.
• Drive continuous improvement using data analysis and metrics across processes and systems.
• Collaborate with engineering, manufacturing, and supply chain to promote a culture of quality.

Skills

Quality engineering

Regulatory compliance

Risk management

Root cause analysis

CAPA

Process improvement

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

Six Sigma

FDA/ISO quality systems

Job description

Markent Personnel is seeking a Quality Engineer to ensure quality standards across the product development lifecycle, from design through post-market support. You'll participate in QD&D during design, support PDP activities, and ensure regulatory compliance.

You will lead root-cause analysis, drive CAPA, collaborate with engineering, manufacturing, and supply chain, and promote continuous improvement with data-driven metrics.